Arrox 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Arrox 5 mg film-coated tablets EFG

Arrox 10 mg film-coated tablets EFG

Arrox 15 mg film-coated tablets

Arrox 20 mg film-coated tablets EFG

Arrox 30 mg film-coated tablets

Arrox 40 mg film-coated tablets EFG

rosuvastatin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Arrox is and what it is used for
2. What you need to know before taking Arrox
3. How to take Arrox
4. Possible side effects
5. How to store Arrox
6. Contents of the pack and other information

1. What Arrox is and what it is used for

Arrox belongs to a group of medicines called statins.

You have been prescribed Arrox because:

• You have high cholesterol levels. This means you are at risk of having a heart attack or stroke. Arrox is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol.
• You have been advised to take a statin because changes in your diet and increased physical activity have not been sufficient to correct your cholesterol levels. You must maintain a cholesterol-lowering diet and continue exercising while taking Arrox.

Or

• You have other risk factors that increase your likelihood of experiencing a heart attack, stroke, or other related health problems.

Heart attack, stroke, and other related health problems may be caused by a condition called atherosclerosis. Atherosclerosis is caused by the buildup of fatty deposits in your arteries.

Why it is important that you continue taking Arrox

Arrox is used to correct levels of fatty substances in the blood called lipids, the most well-known being cholesterol.

There are different types of cholesterol in the blood: "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

• Arrox reduces the amount of "bad" cholesterol and increases "good" cholesterol.
• It works by blocking the production of "bad" cholesterol and improves the body's ability to remove it from the blood.

In most people, high cholesterol levels do not affect how they feel, as they produce no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.

Sometimes, these narrowed vessels can become blocked, preventing blood supply to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of having a heart attack, stroke, or other related health problems.

You need to continue taking Arrox, even after your cholesterol levels have reached the desired level, because it prevents cholesterol levels from rising again and causing the formation of fatty deposits. However, you should stop treatment if your doctor instructs you to do so, or if you become pregnant.

2. What you need to know before taking Arrox

Do not take Arrox

• If you are allergic (hypersensitive) to the active substance or to any of the other components of Arrox (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant while taking Arrox, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Arrox by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C).
• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).

If you are in any of the situations mentioned above (or are unsure), please consult your doctor again.

Also, do not take the higher doses (Arrox 30 mg or 40 mg)

• If you have moderate kidney problems (if in doubt, consult your doctor).
• If your thyroid gland is not functioning properly.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines.
• If you regularly consume large amounts of alcohol.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are taking other medicines called fibrates to lower cholesterol.

If you are in any of the situations mentioned above (or are unsure), please consult your doctor again.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Arrox:

• If you have kidney problems.
• If you have liver problems.
• If you experience repeated or unexplained muscle pain and cramps, have a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by general malaise or fever. Also inform your doctor or pharmacist if you experience persistent muscle weakness.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Arrox or other related medicines.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland is not functioning properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (e.g., ritonavir with lopinavir and/or atazanavir); see “Other medicines and Arrox”.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and Arrox may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Arrox”.
• If you are over 70 years old, as your doctor must determine the appropriate starting dose of Arrox for you.
• If you have severe respiratory insufficiency.
• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must determine the appropriate starting dose of Arrox for you.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If you are in any of the above-mentioned situations (or are unsure):

• Do not take the higher doses of 30 mg and 40 mg, and consult your doctor or pharmacist before starting any dose of Arrox.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Arrox treatment. Stop using Arrox and seek immediate medical attention if you notice any of the symptoms described in section 4.

In a small number of people, statins may affect the liver. This is detected by a simple blood test showing elevated levels of liver enzymes (transaminases). For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with Arrox.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely at increased risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Children and adolescents

• If the patient is under 6 years of age: Arrox must not be given to children under 6 years of age.
• If the patient is under 18 years of age: The 40 mg tablets of Arrox must not be given to children and adolescents under 18 years of age.

Other medicines and Arrox

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking any of the following medicines:

• cyclosporine (used after organ transplantation),
• warfarin, clopidogrel, or ticagrelor (or any other anticoagulant medicine such as acenocoumarol),
• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe),
• treatments for indigestion (used to neutralize stomach acid),
• erythromycin (an antibiotic),
• fusidic acid (an antibiotic – please see below and “Warnings and precautions”),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high levels of uric acid in the blood),
• teriflunomide (used to treat multiple sclerosis),
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medicines may be altered by Arrox, or they may alter the effect of Arrox.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking Arrox. Your doctor will tell you when it is safe to restart Arrox. Taking Arrox with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Pregnancy and breastfeeding

Do not take Arrox if you are pregnant or breastfeeding. If you become pregnant while taking Arrox, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Arrox by using an appropriate contraceptive method.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Most patients can drive and operate machinery while taking Arrox, as it will not affect their ability. However, some people may experience dizziness during treatment with Arrox. If you feel dizzy, consult your doctor before attempting to drive or use machines.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

The complete list of components is in “Contents of the pack and other information”.

3. How to take Arrox

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

If you are taking Arrox for high cholesterol levels:

Starting dose

Your treatment with Arrox should begin with a dose of 5 mg or 10 mg, even if you have previously taken a higher dose of another statin.

The choice of starting dose will depend on:

• Your cholesterol levels.
• Your risk level of having a heart attack or stroke.
• Whether you have factors that make you more susceptible to possible adverse effects.

Check with your doctor or pharmacist which starting dose of Arrox is best for you.

Your doctor may decide to start treatment with the smallest dose (5 mg):

• If you are of Asian origin (e.g., Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian).
• If you are over 70 years old.
• If you have moderate kidney problems.
• If you are at risk of muscle pain and cramps (myopathy).

Dose increase and maximum daily dose

Your doctor may decide to increase your dose so that you receive the appropriate Arrox dose for your condition. If you started with a 5 mg dose, your doctor may decide to double the dose to 10 mg, then to 15 mg or 20 mg, and later to 30–40 mg, if necessary. If you started with a 10 mg dose, your doctor may decide to increase it to 15–20 mg and then to 30–40 mg, if necessary. There will be an interval of four weeks between each dose adjustment.

The maximum daily dose of Arrox is 40 mg. This dose is only for patients with high cholesterol and a high risk of heart attack or stroke whose cholesterol levels do not decrease sufficiently with 20 mg.

If you are taking Arrox to reduce the risk of heart attack, stroke, or related health problems:

The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of the factors mentioned above.

Use in children and adolescents aged 6–17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual starting dose is 5 mg daily, and your doctor may gradually increase the dose until reaching the appropriate Arrox dose for you. The maximum recommended daily dose of Arrox is 10 mg or 20 mg for children aged 6 to 17 years, depending on the underlying condition being treated. Take your dose once daily. Arrox 30 mg and 40 mg tablets must not be administered to children.

How to take the tablets

Swallow each tablet whole with water.

Take Arrox once daily. You may take it at any time of day, with or without food.

Try to take the tablets at the same time each day. This will help you remember to take them.

Regular cholesterol level checks

It is important to visit your doctor regularly for cholesterol checks to ensure your cholesterol levels have normalized and remain at appropriate levels.

Your doctor may decide to increase your dose so that you receive the appropriate Arrox dose for your condition.

If you take more Arrox than you should

Contact your doctor or nearest hospital for advice.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you are admitted to hospital or receive treatment for another condition, inform healthcare staff that you are taking Arrox.

If you forget to take Arrox

Do not worry; simply take the next scheduled dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Arrox

Consult your doctor if you wish to stop treatment with Arrox. Your cholesterol levels may rise again if you stop taking Arrox.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

It is important that you are aware of what these adverse effects may be. They are usually mild and disappear within a short period of time.

Stop taking Arrox and seek immediate medical attention if you experience any of the following allergic reactions:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Severe skin itching (with hives).
• Reddish, flat, non-elevated skin rashes on the trunk, often in a target or circular shape, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also stop taking Arrox and consult your doctor immediately:

• If you experience unexplained muscle pain and cramps lasting longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, a very small number of people have experienced unpleasant muscle effects, which very rarely have led to a potentially life-threatening muscle injury called rhabdomyolysis.
• If you experience muscle rupture.
• If you develop a syndrome with symptoms resembling lupus (including hives, joint disorders, and effects on blood cells).

Common adverse effects (may affect up to 1 in 10 people)

• Headache, stomach pain, constipation, nausea, muscle pain, weakness, dizziness.
• Increased levels of protein in urine – this usually returns to normal on its own without needing to stop treatment with Arrox tablets (common adverse effect only with the daily dose of 40 mg of rosuvastatin).
• Diabetes. This is more likely if you have high blood sugar and lipid levels, are overweight, and have high blood pressure. Your doctor will monitor you closely while you are taking this medicine.

Uncommon adverse effects (may affect up to 1 in 100 people)

• Hives, itching, and other skin reactions.
• Increased levels of protein in urine – this usually returns to normal on its own without needing to stop treatment with Arrox tablets (uncommon adverse effect with daily doses of 5 mg, 10 mg, and 20 mg of rosuvastatin).

Rare adverse effects (may affect up to 1 in 1,000 people)

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and intense skin itching (with hives). If you think you are having an allergic reaction, stop taking Arrox and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Arrox and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of pancreas inflammation).
• Increased liver enzymes (transaminases) in blood.
• Bleeding or bruising more easily than normal due to low platelet levels in the blood.
• Syndrome with symptoms resembling lupus (including rash, joint disorders, and effects on blood cells).

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Jaundice (yellowing of the skin and eyes), hepatitis (inflamed liver), traces of blood in urine, nerve damage in arms and legs (with numbness or tingling), joint pain, memory loss, and breast enlargement in men (gynecomastia).

Adverse effects with unknown frequency (cannot be estimated from available data), which may include

• Diarrhea (loose stools), cough, shortness of breath, edema (swelling), sleep disturbances, including insomnia and nightmares, sexual difficulties, depression, breathing problems, including persistent cough and/or shortness of breath or fever, tendon injuries, and persistent muscle weakness,
• Myasthenia gravis (a condition causing generalized muscle weakness which, in some cases, affects the muscles used for breathing),
• Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arrox

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arrox

• The active substance in Arrox is rosuvastatin. Arrox film-coated tablets contain calcium rosuvastatin equivalent to 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, or 40 mg of rosuvastatin.
• The other components are: lactose monohydrate, microcrystalline cellulose, heavy magnesium oxide, crospovidone, calcium stearate, hypromellose, glyceryl triacetate, titanium dioxide (E171).

Nature of the product and pack contents

Arrox 5 mg are film-coated tablets, white, round, biconvex, and without a score mark.

Arrox 10 mg are film-coated tablets, white, round, biconvex, with a score mark on one side. The score mark is not intended to divide the tablet into equal doses.

Arrox 15 mg are film-coated tablets, white, round, biconvex, and without a score mark.

Arrox 20 mg are film-coated tablets, white, round, biconvex, with a cross engraved on one side.

Arrox 30 mg are film-coated tablets, white, round, biconvex, with a score mark on one side.

Arrox 40 mg are film-coated tablets, white, oval, smooth.

Arrox 5 mg is available in blister packs containing 20, 28, 30, and 60 tablets.

Arrox 10 mg is available in blister packs containing 20, 28, 30, and 60 tablets.

Arrox 15 mg is available in blister packs containing 28, 30, and 60 tablets.

Arrox 20 mg is available in blister packs containing 28, 30, and 60 tablets.

Arrox 30 mg is available in blister packs containing 28, 30, and 60 tablets.

Arrox 40 mg is available in blister packs containing 28, 30, and 60 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Spain Arrox 5 mg/10 mg/20 mg/40 mg film-coated tablets EFG

Arrox 15 mg/30 mg film-coated tablets

Portugal Rosuvastatina Bisten 5 mg/10 mg/20 mg/40 mg film-coated tablets MG

Rosuvastatina Bisten 15 mg/30 mg film-coated tablets

Date of the most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.